In its latest version of guidelines for multiple myeloma treatment, the National Comprehensive Cancer Network (NCCN) recommended the use of Revlimid (lenalidomide) as a maintenance therapy after stem cell transplantation. The NCCN based their decision on the preliminary findings of three Phase 3 trials: MM-015, CALGB 100104, and IFM 2005-02.

“[Revlimid] as maintenance has been evaluated in three independent randomized clinical trials. Results from each of these trials show improvements in time-to-progression,” the NCCN myeloma guidelines state. “The panel felt that this warranted inclusion; however, this recommendation remains Category 2A since these results have not undergone full peer review and safety/efficacy data are still preliminary.”

Recommendations labeled Category 2A are not as well supported by research as those in Category 1. However like Category 1 recommendations, they receive near unanimous approval from the panel, which in this case, consisted of 23 doctors from various institutions.

Currently, Revlimid is only approved by the United States Food and Drug Administration (FDA) in combination with dexamethasone (Decadron) as a second-line treatment. However, many academic medical centers use Revlimid for additional types of myeloma treatment.

“[The Mayo Clinic] has already been recommending maintenance therapy with [Revlimid] for certain patients for over a year, namely those who have failed to achieve a very good partial response after transplant and for those patients who have high-risk cytogenetic features,” wrote Dr. S. Vincent Rajkumar, a Professor of Medicine at the Mayo Clinic, in and email to The Myeloma Beacon.

Medicare uses NCCN guidelines, as well as several other sets of guidelines, to determine whether to pay for treatments if they are used differently than their FDA-approved use. Physicians can also refer to these guidelines when deciding among treatment options for patients.

“The NCCN recommendation may make more patients consider maintenance,” said Dr. Rajkumar.

Based on the preliminary results of MM-015 and other studies, Revlimid’s manufacturer, Celgene Corporation, plans to file for FDA approval of the drug as both an induction therapy in newly diagnosed myeloma and as a maintenance therapy after transplantation sometime this year (see related Beacon news).

Updated data from all three supporting trials are expected to be presented at the American Society of Clinical Oncology meeting in June of this year.

Despite the new NCCN guidelines, Dr. Rajkumar expressed some reservations about expanding the Mayo Clinic’s use of Revlimid maintenance therapy. “The evidence so far with Revlimid is still not definitive. We don’t have [evidence of overall survival benefit] for Revlimid as a maintenance therapy following transplant, so I am reluctant to recommend Revlimid maintenance based on evidence of progression free survival improvement alone.”

For more information, see the NCCN guidelines for multiple myeloma (free registration required) and related Beacon articles about the studies supporting Revlimid maintenance (MM-015, CALGB 100104, and IFM 2005-02).